Colonic Irrigation Nozzle 720400

GUDID B424720400

Large Bulb Speculum with Obturator, California Proposition 65 Material Compliant, Phthalates & DEHP Fee, CCH Part No. 720400

CLEARWATER COLON HYDROTHERAPY, INC.

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• Primary Device ID: B424720400
• NIH Device Record Key: 806bb15e-c348-4493-ae06-18d6e5235e8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Colonic Irrigation Nozzle
• Version Model Number: SP01 Large Bulb Speculum
• Catalog Number: 720400
• Company DUNS: 942667882
• Company Name: CLEARWATER COLON HYDROTHERAPY, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 352-401-0303
• Email: sales@colonhydrotherapy.com
• Phone: 352-401-0303
• Email: sales@colonhydrotherapy.com
• Phone: 352-401-0303
• Email: sales@colonhydrotherapy.com
• Phone: 352-401-0303
• Email: sales@colonhydrotherapy.com
• Phone: 352-401-0303
• Email: sales@colonhydrotherapy.com
• Phone: 352-401-0303
• Email: sales@colonhydrotherapy.com
• Phone: 352-401-0303
• Email: sales@colonhydrotherapy.com
• Phone: 352-401-0303
• Email: sales@colonhydrotherapy.com
• Phone: 352-401-0303
• Email: sales@colonhydrotherapy.com
• Phone: 352-401-0303
• Email: sales@colonhydrotherapy.com
• Phone: 352-401-0303
• Email: sales@colonhydrotherapy.com
• Phone: 352-401-0303
• Email: sales@colonhydrotherapy.com
• Phone: 352-401-0303
• Email: sales@colonhydrotherapy.com
• Phone: 352-401-0303
• Email: sales@colonhydrotherapy.com
• Phone: 352-401-0303
• Email: sales@colonhydrotherapy.com
• Phone: 352-401-0303
• Email: sales@colonhydrotherapy.com
• Phone: 352-401-0303
• Email: sales@colonhydrotherapy.com
• Phone: 352-401-0303
• Email: sales@colonhydrotherapy.com
• Phone: 352-401-0303
• Email: sales@colonhydrotherapy.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Stored in Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored in Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored in Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored in Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored in Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored in Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored in Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored in Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored in Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored in Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored in Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored in Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored in Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored in Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored in Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored in Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored in Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored in Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored in Room Temperature

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B424720400 [Package]; Contains: B4247204000; Package: Plastic Bag [1 Units]; In Commercial Distribution
HIBCC	B4247204000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000388

FDA Product Code

• KPL: Colonic Irrigation System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-09
• Device Publish Date: 2016-09-24

On-Brand Devices [Colonic Irrigation Nozzle]

• B424720400: Large Bulb Speculum with Obturator, California Proposition 65 Material Compliant, Phthalates & D
• B424720300: Large Straight Speculum with Obturator, California Proposition 65 Material Compliant, Phthalates
• B424720200: Small Bulb Speculum with Obturator, California Proposition 65 Material Compliant, Phthalates & D
• B424720100: Small Straight Style Speculum with Obturator, California Proposition 65 Material Compliant, Phth